WOSCOPS: West Of Scotland Coronary Prevention Study
Purpose
To determine whether pravastatin reduces combined incidence of nonfatal MI and death due to coronary heart disease (CHD) in patients with hypercholesterolemia
Reference
Shepherd J, Cobbe SM, Ford I et al. for the West of Scotland Coronary Prevention Study Group. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. New Engl J Med 1995:333:1301–7.
WOSCOPS: West Of Scotland Coronary Prevention Study - TRIAL DESIGN -
Design
Randomized, double-blind, placebo-controlled
Patients
6595 male patients, aged 45–64 years, with high total cholesterol (272 + 23 mg/dL, 7.0 + 0.6 mmol/L) and LDL cholesterol (155–232 mg/dL, 4.0–6.0 mmol/L); patients with history of MI excluded
Follow up and primary endpoint
Combined primary endpoint: nonfatal MI and death due to CHD. Mean 4.9 years follow up
Treatment
Placebo or pravastatin 40 mg each evening
WOSCOPS: West Of Scotland Coronary Prevention Study - RESULTS -
In pravastatin group, compared with placebo, significant reduction in:
Combined endpoint of nonfatal MI or death from CHD
Definite nonfatal MI
Death from all definite cardiovascular causes (1.6 vs. 2.3%, risk reduction 32%, P=0.033)
Myocardial revascularization procedures (1.7 vs. 2.5%, risk reduction 37%, P=0.009)
Reductions in all-cause and CHD mortality not significant
No differences in noncardiovascular death, including death from cancer, trauma or suicide
With pravastatin, total and LDL cholesterol and triglycerides reduced by 20%, 26% and 12%, respectively; HDL cholesterol increased by 5%
Drug well tolerated: similar withdrawal rate in both groups
WOSCOPS: West Of Scotland Coronary Prevention Study - RESULTS continued -
Nonfatal MI or death from coronary heart disease
Shepherd et al. N Engl J Med 1995; 333:1301–70.
WOSCOPS: West Of Scotland Coronary Prevention Study - RESULTS continued -
Years after randomization
% with
event
0
1
2
3
4
5
6
0
6
4
2
8
10
Nonfatal MI and death from coronary heart disease
Definite nonfatal MI
Death definitely from
coronary heart disease
Shepherd et al. N Engl J Med 1995; 333:1301–70.
0
1
2
3
4
5
6
0.0
1.5
1.0
0.5
2.0
2.5
Placebo
Pravastatin
WOSCOPS: West Of Scotland Coronary Prevention Study - SUMMARY -
In patients with hypercholesterolemia and no history of MI, pravastatin reduced:
Combined endpoint of nonfatal MI or death from CHD
Nonfatal MI
Death from all definite cardiovascular causes
Need for myocardial revascularization procedures